Amarin Corporation plc (NASDAQ:AMRN) today announced new supported
and/or funded research on the effects of VASCEPA®/VAZKEPA
(icosapent ethyl) in specific patient subgroups at increased risk
of a cardiovascular (CV) event from the landmark REDUCE-IT®
cardiovascular outcomes trial have been accepted for presentation
at the European Society of Cardiology (ESC) Congress, both online
and onsite in Barcelona, August 26-29, 2022.
The accepted abstracts include a Late-Breaking Science
presentation on reduction of ST-segment Elevation MI with VASCEPA
from the REDUCE-IT trial. These and other new findings will be
presented by a variety of international academic collaborators
based on research or analyses supported by Amarin.
Featured Amarin-supported abstracts to be
presented at ESC Congress 2022 include:
Late-Breaking Science Presentation
- Session: Latest science in primary
and secondary prevention and environmental health
“Significant Reduction in ST-Elevation MI with Icosapent
Ethyl in REDUCE-IT”
Deepak L. Bhatt, Robert P. Giugliano, Ph. Gabriel
Steg, Michael Miller, et al. – Available August 26 at 2:18 p.m.
CEST (8:18 a.m. EST) in room: Dali
Abstract Sessions Presentation
- Session: Optimal risk factor therapy
in high risk patients “Icosapent Ethyl
Diminishes CVD Risk in Smokers: REDUCE-IT
Smoking” Michael Miller, Deepak L. Bhatt, Ph. Gabriel
Steg, Eliot A. Brinton, et al. – Available August 28 at 11:50 a.m.
CEST (5:50 a.m. EST) in room: Science Box 3
“We are pleased to support these Late Breaking Science and Oral
Presentations at the upcoming ESC Congress being held later this
month,” said Nabil Abadir, MB. CH.B., SVP, Chief Medical Officer
and Head of Global Medical Affairs, Amarin. “These data continue to
underscore the clinical and therapeutic utility and value of
VASCEPA/VAZKEPA and continue to validate the clinical outcomes
shown in the overall REDUCE-IT trial. As we know, REDUCE-IT
demonstrated the clear risk reduction benefits of icosapent ethyl
in reducing cardiovascular events among patients most at risk for
cardiovascular disease including those with previous cardiovascular
events, such as myocardial infarction (MI) or stroke. We are proud
of the continued work that is being done to further demonstrate the
proven efficacy of VASCEPA in cardiovascular risk reduction while
providing support to investigators to explore other ways in which
VASCEPA can potentially help patients and impact public
health.”
About Amarin Amarin is an innovative
pharmaceutical company leading a new paradigm in cardiovascular
disease management. From our scientific research foundation to our
focus on clinical trials, and now our commercial expansion, we are
evolving and growing rapidly. Amarin has offices in Bridgewater,
New Jersey in the United States, Dublin in Ireland, and Zug in
Switzerland as well as commercial partners and suppliers around the
world. We are committed to rethinking cardiovascular risk through
the advancement of scientific understanding of the impact on
society of significant residual risk that exists beyond traditional
therapies, such as statins for cholesterol management.
About Cardiovascular Risk Cardiovascular
disease is the number one cause of death in the world. In the
United States alone, cardiovascular disease results in 859,000
deaths per year.1 And the number of deaths in the United States
attributed to cardiovascular disease continues to rise. In
addition, in the United States there are 605,000 new and 200,000
recurrent heart attacks per year (approximately 1 every 40
seconds). Stroke rates are 795,000 per year (approximately 1 every
40 seconds), accounting for 1 of every 19 U.S. deaths. In
aggregate, in the United States alone, there are more than 2.4
million major adverse cardiovascular events per year from
cardiovascular disease or, on average, 1 every 13
seconds.
Controlling bad cholesterol, also known as LDL-C, is one way to
reduce a patient’s risk for cardiovascular events, such as heart
attack, stroke or death. However, even with the achievement of
target LDL-C levels, millions of patients still have significant
and persistent risk of cardiovascular events, especially those
patients with elevated triglycerides. Statin therapy has been shown
to control LDL-C, thereby reducing the risk of cardiovascular
events by 25-35%.2 Significant cardiovascular risk remains after
statin therapy. People with elevated triglycerides have 35% more
cardiovascular events compared to people with normal (in range)
triglycerides taking statins.3,4,5
About REDUCE-IT® REDUCE-IT was a global
cardiovascular outcomes study designed to evaluate the effect of
VASCEPA in adult patients with LDL-C controlled to between 41-100
mg/dL (median baseline 75 mg/dL) by statin therapy and various
cardiovascular risk factors including persistent elevated
triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and
either established cardiovascular disease (secondary prevention
cohort) or diabetes mellitus and at least one other cardiovascular
risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and completed in 2018,
followed 8,179 patients at over 400 clinical sites in 11 countries
with the largest number of sites located within the United States.
REDUCE-IT was conducted based on a special protocol assessment
agreement with FDA. The design of the REDUCE-IT study was published
in March 2017 in Clinical Cardiology.6 The primary results of
REDUCE-IT were published in The New England Journal of Medicine in
November 2018.7 The total events results of REDUCE-IT were
published in the Journal of the American College of Cardiology in
March 2019.8 These and other publications can be found in the
R&D section on the company’s website
at www.amarincorp.com.
About
VASCEPA®/VAZKEPA®
(icosapent ethyl) Capsules
VASCEPA capsules are the first prescription
treatment approved by the U.S. Food and Drug Administration (FDA)
comprised solely of the active ingredient, icosapent ethyl, a
unique form of eicosapentaenoic acid. VASCEPA was launched in the
United States in January 2020 as the first and only drug approved
by the U.S. FDA for treatment of the studied high-risk patients
with persistent cardiovascular risk after statin therapy. VASCEPA
was initially launched in the United States in 2013 based on the
drug’s initial FDA approved indication for use as an adjunct
therapy to diet to reduce triglyceride levels in adult patients
with severe (≥500 mg/dL) hypertriglyceridemia. Since launch,
VASCEPA has been prescribed over 18 million times. VASCEPA is
covered by most major medical insurance plans. In addition to the
United States, icosapent ethyl is approved and sold in Canada,
Lebanon, Germany and the United Arab Emirates. In Europe, in March
2021 marketing authorization was granted to icosapent ethyl in the
European Union for the reduction of risk of cardiovascular events
in patients at high cardiovascular risk, under the brand name
VAZKEPA. In April 2021 marketing authorization for VAZKEPA
(icosapent ethyl) was granted in Great Britain. The Great Britain
Marketing Authorization for VAZKEPA applies to England, Scotland
and Wales.
United States Indications and
Limitation of Use
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce
the risk of myocardial infarction, stroke, coronary
revascularization and unstable angina requiring hospitalization in
adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL)
and
- established cardiovascular disease
or
- diabetes mellitus and two or more
additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients
with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients
with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of
its components.
- VASCEPA was associated with an increased risk (3% vs 2%) of
atrial fibrillation or atrial flutter requiring hospitalization in
a double-blind, placebo-controlled trial. The incidence of atrial
fibrillation was greater in patients with a previous history of
atrial fibrillation or atrial flutter.
- It is not known whether patients with allergies to fish and/or
shellfish are at an increased risk of an allergic reaction to
VASCEPA. Patients with such allergies should discontinue VASCEPA if
any reactions occur.
- VASCEPA was associated with an increased risk (12% vs 10%) of
bleeding in a double-blind, placebo-controlled trial. The incidence
of bleeding was greater in patients receiving concomitant
antithrombotic medications, such as aspirin, clopidogrel or
warfarin.
- Common adverse reactions in the cardiovascular outcomes trial
(incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal
pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs
4%), gout (4% vs 3%), and atrial fibrillation (5% vs
4%).
- Common adverse reactions in the hypertriglyceridemia trials
(incidence >1% more frequent than placebo): arthralgia (2% vs
1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by calling 1-855-VASCEPA or the
FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants
and/or anti-platelet agents should be monitored for
bleeding.
FULL U.S. FDA-APPROVED
VASCEPA PRESCRIBING
INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Europe For further information about the
Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe,
please click here. Globally, prescribing
information varies; refer to the individual country product label
for complete information.
Forward-Looking Statements This press
release contains forward-looking statements which are made pursuant
to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, including beliefs about the potential for
VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent
ethyl (IPE)’s role concerning patients suffering from
cardiovascular disease (CVD) and impacts on the risk of heart
attack, stroke or other fatal or non-fatal cardiovascular events
for patients who suffered a prior heart attack, as well as general
beliefs about the safety and effectiveness of VASCEPA. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. A further list and
description of these risks, uncertainties and other risks
associated with an investment in Amarin can be found in Amarin's
filings with the U.S. Securities and Exchange Commission, including
Amarin’s annual report on Form 10-K for the full year ended 2021.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date they are made. Amarin undertakes no obligation to
update or revise the information contained in its forward-looking
statements, whether as a result of new information, future events
or circumstances or otherwise. Amarin’s forward-looking statements
do not reflect the potential impact of significant transactions the
company may enter into, such as mergers, acquisitions,
dispositions, joint ventures or any material agreements that Amarin
may enter into, amend or terminate. Availability of Other
Information About Amarin communicates with its investors and the
public using the company website (www.amarincorp.com) and the
investor relations website (investor.amarincorp.com), including but
not limited to investor presentations, Securities and Exchange
Commission filings, press releases, public conference calls and
webcasts. The information that Amarin posts on these channels and
websites could be deemed to be material information. As a result,
Amarin encourages investors, the media and others interested in
Amarin to review the information that is posted on these channels,
including the investor relations website, on a regular basis. This
list of channels may be updated from time to time on Amarin’s
investor relations website and may include social media channels.
The contents of Amarin’s website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
Availability of Other Information About
Amarin Investors and others should note that Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations and investor FAQs, Securities and Exchange Commission
filings, press releases, public conference calls and webcasts. The
information that Amarin posts on these channels and websites could
be deemed to be material information. As a result, Amarin
encourages investors, the media, and others interested in Amarin to
review the information that is posted on these channels, including
the investor relations website, on a regular basis. This list of
channels may be updated from time to time on Amarin’s investor
relations website and may include social media channels. The
contents of Amarin’s website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
Amarin Contact
Information Investor
Inquiries: Investor Relations Amarin Corporation
plc In U.S.: +1 (908)
719-1315 IR@amarincorp.com
Media
Inquiries: Communications Amarin Corporation
plc In U.S.: +1 (908)
892-2028 PR@amarincorp.com
AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are trademarks of Amarin
Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark
in Europe and other countries and regions and is pending
registration in the United States.
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